In the administration of medicinal liquids using intravenous techniques, it is important and critical to avoid contamination of sterile devices used in the administration of the fluids and to avoid the occurrence of accidental needle sticks which at the very least causes pain and discomfort and can spread infection, etc. In particular, not only are the patients at risk throughout the administration of intravenous therapy due to accidental needle sticks but also, the care giver and other individuals are exposed to considerable risks unless appropriate safety precautions are followed at all times.
Based on the need to provide a safer administration system, there has been a trend in the health care industry toward the reduction and elimination of steel needles in connection with intravenous therapy. In some products instead of using a steel needle to penetrate a port of a catheter which has been installed at a target, select access point along a patient's body, the products use a variety of plastic coupling members for placing the catheter in communication with a conduit, etc.
FIG. 1 shows a conventional infusion bag 10 that has a flexible body 20 that includes a closed top edge 22 and a bottom edge 24. The bottom edge 24 includes a first port 30 for injecting fluids, such as infusion fluid and other additives (e.g., vitamins) into an interior of the bag 10. The bottom edge 24 includes a second port 40 that is in communication with the interior of the bag 10. The second port 40 is also commonly referred to as a spike port and serves as the port through which the contents of the bag 10 are discharged as when an infusion line (conduit) that attaches to a patient is sealingly coupled to the second port 40. The bag 10 can also include a transfer line or fill leg 50 through which ingredients can be added to the bag 10 under some application, such as when compounding total parenteral nutrition (TPN). As is known, TPN is the practice of feeding a person intravenously, bypassing the usual process of eating and digestion. The person receives nutritional formulas containing salts, glucose, amino acids, lipids and added vitamins.
There are a number of deficiencies with the construction of bag 10. First, air must be removed from the body 20 of the bag 10 prior to sending the bag 10 out to a patient. This is called “airing” the bag 10. This is a very tedious process that requires the bag 10 to be turned upside down so that the bottom edge 24 and the ports 30, 40, 50 face up and the bag 10 is shaken to get the air to go to one side or the other side. A needle is then inserted into one of the ports, such as port 30, and the air is removed. Unfortunately and disadvantageously, this frequently requires numerous sticks as air tends to collect around the ports 30, 40, 50. The second disadvantage of the bag construction occurs when the patient is required to add vitamins or other additives to the bag 10 prior to injecting the contents (e.g., infusion fluid). This requires the patient to attach a needle to a syringe or the like prior to injecting the contents. One will appreciate that in both instances, the technician and the patient him or herself are at risk for needle sticks due to the use of needles to perform both operations.
There is thus a perceived need for an improved infusion bag construction that overcomes the both disadvantages associated with conventional infusion bags and eliminates the risk of needle sticks when “airing” the bag and when injecting additives to the bag.